FDA Remote Gap Audit – Regulatory Support

How It Works:

• Remote gap audit 
• Remote review of current plans, documents, and forms to see (1) are they written to the current regulation standards (2) what, if any is missing.
• After reviewing, a detailed report of the current status and any recommendation to fill the gaps. 
• Gap audit will review regulations based on company size and production methods to cover aspects of: FDA, FSMA, cGMP, HACCP, FSVP, PCQI, SSOP, Food Defense, Label Law, COOL, OSHA, etc.

WORKFLOW:

The Company and Agent agree to the below workflow for each assigned job:

• Agreement signed, mutual NDA signed
• Upload of all regulatory SOPs, and forms safe server
• Phone Call to discuss in more detail production methods
• Review of all documentation
• Report written to detail the good, the bad, and the needs / work
• Proposal written to fill in the gaps
• Report and proposal sent to you
• Phone call schedule to answer any questions once reviewed
• Documents uploaded to server purged and removed from server